Treats cyclic heavy menstrual bleeding in females of reproductive potential. ANDA 202093, held by Actavis Labs Fl Inc. Tranexamic Acid.
As of Nov 15, 2026, ANDA 202093 (Tranexamic Acid), held by Actavis Labs Fl Inc, was first approved by FDA on Dec 27, 2012, with 2 approved supplements and 0 published complete response letters.
Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid650MG · tablet;oral | Tranexamic Acid | Rx |
| Dec 22, 2021 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 20, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 27, 2012 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
